Regulatory Affairs & Quality Assurance Specialist – Food & Drug (SFDA)

Job Title

Experience

Role Purpose

Key Responsibilities

• Submit and follow up on registration, licensing, and notification applications with the SFDA through its electronic platforms for each sector.
• Develop and implement written Standard Operating Procedures (SOPs) for product tracking, transport, storage, complaints/reports, and safety alert notifications (recall / withdrawal).
• Build, operate, and document the product tracking system (including providing a system screenshot/report on request).
• Prepare and maintain the Quality Management System (QMS) file and review it periodically.
• Monitor SFDA warnings, circulars, and decisions, and update the company's procedures accordingly.
• Manage safety reports and recall cases per SFDA requirements, and coordinate official communication with the Authority.
• Identify the ISO certifications required for each activity and oversee their fulfillment (detailed below).
• Maintain regulatory records and documentation in an organized manner, ready for audit and inspection.

Relevant ISO Standards by Activity

• Food: ISO 22000 (Food Safety Management System, integrating HACCP principles) and FSSC 22000.
• Medical devices (where applicable): SFDA.MD / GSO ISO 13485, or equivalent, as the baseline quality management system for medical device establishment licensing and marketing authorization.
• General quality: ISO 9001 (Quality Management).

Qualifications & Skills

• Bachelor's degree strictly in one of the following: Pharmacy / Pharmaceutical Sciences (drug track), or Food Science & Technology / Food Safety / Food Nutrition (food track).
• Practical knowledge of SFDA regulations, its electronic platforms, and registration/tracking procedures for each sector.
• Experience in developing and implementing written SOPs and quality management systems.
• Fluency in Arabic; English is essential (many SFDA guidelines and ISO standards are in English).
• Accuracy, organization, and the ability to manage multiple regulatory files simultaneously.